Trial Outcomes & Findings for Sugar-replacement Sweeteners, and Blood Sugar Control (NCT NCT01128829)

Results Overview

we will measure plasma insulin concentrations during a 5-hour modified Oral Glucose Tolerance Test (mOGTT) administered 10 minutes after subjects consume sucralose in water or an equal volume of water without sucralose (control condition).Plasma insulin concentrations were measured at 20, 15, 10, 6, and 2 min before and at 10, 20, 30, 40, 60, 90, 120, 150,180, 240, and 300 min after ingesting 75g of glucose. All these data collected were used to create the AUC curve.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

17 participants

Primary outcome timeframe

Baseline

Results posted on

2014-12-22

Participant Flow

Participant milestones

Participant milestones
Measure	"Water Then Sucralose" First intervention (1 day) subjects drank 60 ml of water 10 min before drinking a 75 g glucose load. Washout (\~ 7 days) Second intervention (1 day) subjects drank 60 ml of 2 mmolar sucralose 10 min before drinking a 75 g glucose load.	"Sucralose Then Water" First intervention (1 day) subjects drank 60 ml of 2 mmolar sucralose10 min before drinking a 75 g glucose load. Washout (\~ 7 days) Second intervention (1 day) subjects drank 60 ml of water 10 min before drinking a 75 g glucose load.
Overall Study STARTED	6	11
Overall Study COMPLETED	6	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sugar-replacement Sweeteners, and Blood Sugar Control

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Obese Non Regular Users of Non Nutritive Sweeteners (NNS) n=17 Participants Obese subjects who do not use NNS and are "insulin-sensitive" (based on a Homeostasis Model Assessment of Insulin Resistance score \<or =2.6).
Age, Continuous	35.1 years STANDARD_DEVIATION 4.1 • n=93 Participants
Sex: Female, Male Female	15 Participants n=93 Participants
Sex: Female, Male Male	2 Participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline

we will measure plasma insulin concentrations during a 5-hour modified Oral Glucose Tolerance Test (mOGTT) administered 10 minutes after subjects consume sucralose in water or an equal volume of water without sucralose (control condition).Plasma insulin concentrations were measured at 20, 15, 10, 6, and 2 min before and at 10, 20, 30, 40, 60, 90, 120, 150,180, 240, and 300 min after ingesting 75g of glucose. All these data collected were used to create the AUC curve.

Outcome measures

Outcome measures
Measure	Obese Non Regular Users of Non Nutritive Sweeteners (NNS) n=17 Participants Obese subjects who do not use NNS and are "insulin-sensitive" (based on a Homeostasis Model Assessment of Insulin Resistance score \<or =2.6).
The Effect of Sucralose on Insulin Concentration (Area Under the Curve; AUC) Insulin AUC on water day	57,192 (pmol • min •L-1) Standard Deviation 23,270
The Effect of Sucralose on Insulin Concentration (Area Under the Curve; AUC) Insulin AUC on sucralose day	68,647 (pmol • min •L-1) Standard Deviation 31,201

Adverse Events

Obese Non Regular Users of Non Nutritive Sweeteners (NNS)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

M. Yanina Pepino

Washington University School of Medicine

Phone: 3143628113

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place